Can-Fite says liver cancer trial is delayed—but it could be good news

Israeli microcap Can-Fite BioPharma won’t get a readout from its midstage trial of liver cancer candidate namodenoson as soon as it hoped, but said the data so far are looking good.

One of the reasons for the delay is the "the unexpected longevity of patients enrolled into this trial," said the biotech’s medical director Michael Silverman, M.D. The company still expects to get overall survival data from the study before the end of the year.

There’s no guarantee that long survival is down to Can-Fite’s drug, of course, as data from the study remain blinded. However, shares in the company were on the rise in premarket trading this morning after the company gave its update.

The study involves 78 patients with hepatocellular carcinoma (HCC)—the most common form of liver cancer—who failed prior treatment with Bayer’s standard first-line drug Nexavar, which approached $1 billion in sales last year.

In the 78-subject trial, the A3 adenosine receptor (A3AR) agonist, which was originated by researchers at the National Institutes of Health, is being compared to placebo on a range of endpoints, including overall survival, progression-free survival and safety.  

The study is also investigating the relationship between clinical outcomes and A3AR expression in the patients, who have a Child Pugh score of B, meaning they have mild-to-moderate liver impairment. A3AR is highly expressed HCC, and drugs that interact with the receptor have been shown to have both anti-inflammatory and anticancer effects, stimulating programmed cell death in tumor cells.

Patients in the study have been treated for up to three years to date, and 19 subjects have been treated with namodenoson for at least a year. If an improvement in overall survival can be shown, it would be "a critical advance for treating patients with HCC," said Silverman.

The drug is also in phase II trials for nonalcoholic steatohepatitis, a common noncancerous liver disease with no FDA-approved treatments, as well as earlier-stage studies in colon, prostate and skin cancer. The NASH study is due to generate results in 2019.

While the delayed trial may prove to be good news for Can-Fite, there have been some concerns about the company’s financial position. In March, analysts at Maxim Group said the company is heading toward a burn of around $21 million this year, but had a cash balance of $8 million at the end of the first quarter.

Since then, the company has received an upfront payment of $2.2 million from Gebro in a licensing deal for its lead drug—piclidenoson for rheumatoid arthritis—in three European countries.